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Evidence Record

evt_NCT02340221_v62_v63_5d3309fece04

NCT02340221 · A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

View field-level diff Canonical JSON Supersession index ClinicalTrials.gov
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. This page states what the registry evidence supports and what it does not support.
Triage severity
Triage: High
Category
Status Termination
Versions
v62 to v63
Timing
Post Recruitment

Claims Supported

  • TrialDiff compared ClinicalTrials.gov record version 62 to version 63 for NCT02340221.
  • The JSON Patch for this comparison has hash aed0373559cde1269ae3d15d3e52bd59c1dfa893fbe4a50f692a8ba180e1b02d.
  • The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.
  • The deterministic triage label was high; before timing adjustment it was high.
  • The triage label is uncalibrated metadata, not a validated review-priority finding.
  • The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.
  • A registry field under the status or stopped-trial explanation module changed between ClinicalTrials.gov versions 62 and 63.
  • The timing context for the from-version record was post_recruitment.
  • The deterministic rules that fired were: adverse_event_group_change, other_adverse_event_addition, other_adverse_event_modification, serious_adverse_event_addition, serious_adverse_event_modification, terminal_status_change, why_stopped_change.
  • The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/whyStopped, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/1, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, 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  • The timeline value moved by 1353 days.
  • An outcome path changed between versions 62 and 63 in a patch that also carried a hasResults or resultsSection co-occurrence signal.
  • The changed paths include the ClinicalTrials.gov whyStopped field, a stopped-trial explanation field relevant to 42 CFR 11.64 when applicable.

Claims Not Supported

  • That the amendment was scientifically unjustified.
  • That the change constitutes misconduct or wrongdoing.
  • That sponsor intent can be inferred from this registry change.
  • That the change caused or altered the trial's results.
  • That the change was or was not disclosed in a manuscript.
  • That TrialDiff determines regulatory compliance or non-compliance.
  • That TrialDiff determines whether the stopped-trial explanation satisfies 42 CFR 11.64.
  • That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.
  • That event-class membership is a validated global review-priority ranking.

Neutral Review Question

Does the public registry record give a specific explanation for the stopped or terminal status?

Citation

TrialDiff Evidence Record evt_NCT02340221_v62_v63_5d3309fece04. ClinicalTrials.gov NCT02340221, versions 62-63. Evidence version 1.

Event Classes

outcome_edit_cooccurs_with_results_posting

Changed Paths

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/resultsSection/adverseEventsModule/otherEvents/43/stats/1/numEvents
/resultsSection/adverseEventsModule/otherEvents/44
/resultsSection/moreInfoModule/pointOfContact/email
/resultsSection/moreInfoModule/pointOfContact/phone

View the field-level diff for before/after values on each changed path.

Deterministic Rules

adverse_event_group_changeother_adverse_event_additionother_adverse_event_modificationserious_adverse_event_additionserious_adverse_event_modificationterminal_status_changewhy_stopped_change

Provenance

Package generation
v0.1.3 (active)
Supersedes
evt_NCT02340221_v62_v63_24d455c20a60
Patch hash
aed0373559cde1269ae3d15d3e52bd59c1dfa893fbe4a50f692a8ba180e1b02d
Canonical hash
419b3c09479200f279bb10b70523cadbed808da570b0681e9905a8fc587e8fca
Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621
From snapshot
fc4ac65d31ca1dde11173ec9317a57bac94540d7ee3ee48f984d11157b1627c9
To snapshot
Unavailable
Patch source
ctgov_internal_history
Generated at
2026-08-03T06:46:43.000Z
Source URL
Registry payload

Canonical JSON Preview

Stored payload 
{
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    "/protocolSection/statusModule/whyStopped",
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    "/protocolSection/outcomesModule/secondaryOutcomes/11",
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    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4/type",
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    "/resultsSection/participantFlowModule/preAssignmentDetails",
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    "/resultsSection/baselineCharacteristicsModule/measures/2/classes/2/categories/0/measurements/2/value",
    "/resultsSection/baselineCharacteristicsModule/measures/2/classes/3",
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  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT02340221_v62_v63_5d3309fece04. ClinicalTrials.gov NCT02340221, versions 62-63. Evidence version 1.",
  "claims_not_supported": [
    "That the amendment was scientifically unjustified.",
    "That the change constitutes misconduct or wrongdoing.",
    "That sponsor intent can be inferred from this registry change.",
    "That the change caused or altered the trial's results.",
    "That the change was or was not disclosed in a manuscript.",
    "That TrialDiff determines regulatory compliance or non-compliance.",
    "That TrialDiff determines whether the stopped-trial explanation satisfies 42 CFR 11.64.",
    "That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 62 to version 63 for NCT02340221.",
    "The JSON Patch for this comparison has hash aed0373559cde1269ae3d15d3e52bd59c1dfa893fbe4a50f692a8ba180e1b02d.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "The deterministic triage label was high; before timing adjustment it was high.",
    "The triage label is uncalibrated metadata, not a validated review-priority finding.",
    "The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.",
    "A registry field under the status or stopped-trial explanation module changed between ClinicalTrials.gov versions 62 and 63.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: adverse_event_group_change, other_adverse_event_addition, other_adverse_event_modification, serious_adverse_event_addition, serious_adverse_event_modification, terminal_status_change, why_stopped_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/whyStopped, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/1, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, 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    "The timeline value moved by 1353 days.",
    "An outcome path changed between versions 62 and 63 in a patch that also carried a hasResults or resultsSection co-occurrence signal.",
    "The changed paths include the ClinicalTrials.gov whyStopped field, a stopped-trial explanation field relevant to 42 CFR 11.64 when applicable."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "status_termination",
      "serious_adverse_event_addition",
      "serious_adverse_event_modification",
      "adverse_event_group_change",
      "timeline_actual_date_correction",
      "other_adverse_event_addition",
      "other_adverse_event_modification",
      "results_reconciliation"
    ],
    "category": "status_termination",
    "deterministic_rules": [
      "adverse_event_group_change",
      "other_adverse_event_addition",
      "other_adverse_event_modification",
      "serious_adverse_event_addition",
      "serious_adverse_event_modification",
      "terminal_status_change",
      "why_stopped_change"
    ],
    "event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "high",
    "severity_pre_timing": "high",
    "timing_context": "post_recruitment",
    "triage_label": "high",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "timeline_actual_date_correction",
        "date_struct": "primaryCompletionDateStruct",
        "delta_days": 1353,
        "direction": "later",
        "new_precision": "day",
        "new_type": "ACTUAL",
        "new_value": "2021-06-29",
        "old_precision": "day",
        "old_type": "ACTUAL",
        "old_value": "2017-10-15",
        "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
        "severity": "low",
        "signal": "timeline_actual_date_correction"
      },
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/primaryOutcomes/1",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/10",
          "/protocolSection/outcomesModule/secondaryOutcomes/11",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/6",
          "/protocolSection/outcomesModule/secondaryOutcomes/7",
          "/protocolSection/outcomesModule/secondaryOutcomes/8",
          "/protocolSection/outcomesModule/secondaryOutcomes/9"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT02340221_v62_v63_5d3309fece04",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2022-07"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/overallStatus",
      "value": "TERMINATED"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
      "value": "2021-06-29"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2022-07-11"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2022-07-12"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/whyStopped",
      "value": "The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "value": "Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1",
      "value": {
        "description": "PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
        "measure": "PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis",
        "timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "value": "Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "value": "Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions)."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
      "value": "Overall Survival (OS) at Primary Analysis"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "value": "OS was defined as the time from the date of randomization to the date of death due to any cause."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "value": "From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
      "value": "OS at Final Analysis"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
      "value": "OS was defined as the time from the date of randomization to the date of death due to any cause."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
      "value": "From randomization up to death from any cause (up to approximately 6.2 years)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
      "value": "Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
      "value": "Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization.\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
      "value": "Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
      "value": "Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization.\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
      "value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/6",
      "value": {
        "description": "Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nDisease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
        "measure": "Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis",
        "timeFrame": "Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/7",
      "value": {
        "description": "Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nDisease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
        "measure": "Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis",
        "timeFrame": "Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/8",
      "value": {
        "description": "PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
        "measure": "PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis",
        "timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/9",
      "value": {
        "description": "PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
        "measure": "PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis",
        "timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/10",
      "value": {
        "description": "An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.",
        "measure": "Percentage of Participants With Adverse Events at Primary Analysis",
        "timeFrame": "From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years."
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/11",
      "value": {
        "description": "An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.",
        "measure": "Percentage of Participants With Adverse Events at Final Analysis",
        "timeFrame": "From randomization up to approximately 6.2 years"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/groups/0/description",
      "value": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/groups/1/description",
      "value": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor."
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/0/numSubjects",
      "value": "100"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/1/numSubjects",
      "value": "197"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/0/numSubjects",
      "value": "24"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/1/numSubjects",
      "value": "37"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/0/numSubjects",
      "value": "4"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/1/numSubjects",
      "value": "15"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/0/numSubjects",
      "value": "85"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/1/numSubjects",
      "value": "165"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4/type",
      "value": "Study Terminated by Sponsor"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4/reasons/0/numSubjects",
      "value": "1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4/reasons/1/numSubjects",
      "value": "3"
    },
    {
      "op": "add",
      "path": "/resultsSection/participantFlowModule/preAssignmentDetails",
      "value": "The study enrolled postmenopausal women with estrogen receptor-positive and human epidermal receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who had disease recurrence or progression during or after aromatase inhibitor therapy.\nRandomization was stratified by three factors: 1) visceral versus non-visceral disease, 2) sensitivity versus non-sensitivity to most recent endocrine therapy, and 3) geographical region."
    },
    {
      "op": "add",
      "path": "/resultsSection/participantFlowModule/recruitmentDetails",
      "value": "This study was conducted at 155 centers in 28 countries."
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/2/title",
      "value": "Not Stated"
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/2/categories/0/measurements/0/value",
      "value": "15"
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/2/categories/0/measurements/1/value",
      "value": "15"
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/2/categories/0/measurements/2/value",
      "value": "30"
    },
    {
      "op": "add",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/3",
      "value": {
        "categories": [
          {
            "measurements": [
              {
                "groupId": "BG000",
                "value": "7"
              },
              {
                "groupId": "BG001",
                "value": "20"
              },
              {
                "groupId": "BG002",
                "value": "27"
              }
            ]
          }
        ],
        "title": "Unknown"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/title",
      "value": "Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/type",
      "value": "PRIMARY"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/title",
      "value": "PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
      "value": "PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
      "value": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/paramType",
      "value": "MEDIAN"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/unitOfMeasure",
      "value": "months"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
      "value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/0/value",
      "value": "176"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/1/value",
      "value": "340"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/value",
      "value": "5.55"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/lowerLimit",
      "value": "3.75"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/upperLimit",
      "value": "7.33"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1/value",
      "value": "8.05"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1/lowerLimit",
      "value": "7.33"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1/upperLimit",
      "value": "9.10"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/pValue",
      "value": "0.0008"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/statisticalMethod",
      "value": "Log Rank"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/paramType",
      "value": "Hazard Ratio (HR)"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/paramValue",
      "value": "0.71"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/ciPctValue",
      "value": "95"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/ciNumSides",
      "value": "TWO_SIDED"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/ciLowerLimit",
      "value": "0.58"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/analyses/0/ciUpperLimit",
      "value": "0.87"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title",
      "value": "Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
      "value": "PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions)."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
      "value": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/paramType",
      "value": "NUMBER"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/unitOfMeasure",
      "value": "percentage of participants"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
      "value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms/0/counts/0/value",
      "value": "134"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms/0/counts/1/value",
      "value": "264"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/0/value",
      "value": "11.9"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/0/lowerLimit",
      "value": "7.1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/0/upperLimit",
      "value": "18.3"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/0/comment"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/value",
      "value": "28.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/lowerLimit",
      "value": "22.7"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/upperLimit",
      "value": "33.8"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes/0/categories/0/measurements/1/comment"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/paramType",
      "value": "Odds Ratio (OR)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/paramValue",
      "value": "3.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/ciLowerLimit",
      "value": "1.6"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/ciUpperLimit",
      "value": "5.4"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/pValue",
      "value": "0.0002"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/analyses/0/statisticalMethod",
      "value": "Cochran-Mantel-Haenszel"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/title",
      "value": "Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description",
      "value": "PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions)."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
      "value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/value",
      "value": "13.4"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/lowerLimit",
      "value": "8.2"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/upperLimit",
      "value": "20.2"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/value",
      "value": "31.1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/lowerLimit",
      "value": "25.5"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/upperLimit",
      "value": "36.8"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/analyses",
      "value": [
        {
          "ciLowerLimit": "1.7",
          "ciNumSides": "TWO_SIDED",
          "ciPctValue": "95",
          "ciUpperLimit": "5.4",
          "groupIds": [
            "OG000",
            "OG001"
          ],
          "nonInferiorityType": "SUPERIORITY",
          "pValue": "<0.0001",
          "paramType": "Odds Ratio (OR)",
          "paramValue": "3.1",
          "statisticalMethod": "Cochran-Mantel-Haenszel"
        }
      ]
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/title",
      "value": "Overall Survival (OS) at Primary Analysis"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description",
      "value": "OS was defined as the time from the date of randomization to the date of death due to any cause."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription",
      "value": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame",
      "value": "From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/0/value",
      "value": "176"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/1/value",
      "value": "340"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/value",
      "value": "23.56"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/lowerLimit",
      "value": "18.00"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/value",
      "value": "26.81"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/lowerLimit",
      "value": "21.29"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/upperLimit",
      "value": "NA"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/comment",
      "value": "Upper limit of confidence interval was not estimable due to the low number of participants with events."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses/0/paramValue",
      "value": "0.85"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses/0/ciLowerLimit",
      "value": "0.58"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses/0/ciUpperLimit",
      "value": "1.25"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses/0/pValue",
      "value": "0.4151"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/analyses/0/statisticalMethod",
      "value": "Log Rank"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/title",
      "value": "OS at Final Analysis"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
      "value": "OS was defined as the time from the date of randomization to the date of death due to any cause."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
      "value": "From randomization up to death from any cause (up to approximately 6.2 years)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/value",
      "value": "27.93"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/lowerLimit",
      "value": "24.38"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/upperLimit",
      "value": "NA"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/comment",
      "value": "Upper limit of confidence interval was not estimable due to the low number of participants with events."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/value",
      "value": "27.79"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/lowerLimit",
      "value": "24.25"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/upperLimit",
      "value": "33.35"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/analyses/0/pValue",
      "value": "0.9974"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/analyses/0/paramValue",
      "value": "1.00"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/analyses/0/ciLowerLimit",
      "value": "0.75"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/analyses/0/ciUpperLimit",
      "value": "1.33"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/title",
      "value": "Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description",
      "value": "Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization.\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/populationDescription",
      "value": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/timeFrame",
      "value": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/0/value",
      "value": "134"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/1/value",
      "value": "264"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/0/value",
      "value": "37.3"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/0/lowerLimit",
      "value": "29.1"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/0/upperLimit",
      "value": "45.7"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/value",
      "value": "51.5"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/lowerLimit",
      "value": "45.3"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/upperLimit",
      "value": "57.7"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/dispersionType",
      "value": "95% Confidence Interval"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/analyses",
      "value": [
        {
          "ciLowerLimit": "1.2",
          "ciNumSides": "TWO_SIDED",
          "ciPctValue": "95",
          "ciUpperLimit": "2.9",
          "groupIds": [
            "OG000",
            "OG001"
          ],
          "nonInferiorityType": "SUPERIORITY",
          "paramType": "Odds Ratio (OR)",
          "paramValue": "1.9"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7",
      "value": {
        "analyses": [
          {
            "ciLowerLimit": "1.2",
            "ciNumSides": "TWO_SIDED",
            "ciPctValue": "95",
            "ciUpperLimit": "3.0",
            "groupIds": [
              "OG000",
              "OG001"
            ],
            "nonInferiorityType": "SUPERIORITY",
            "paramType": "Odds Ratio (OR)",
            "paramValue": "1.9"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "groupId": "OG000",
                    "lowerLimit": "37.2",
                    "upperLimit": "54.3",
                    "value": "45.5"
                  },
                  {
                    "groupId": "OG001",
                    "lowerLimit": "53.6",
                    "upperLimit": "65.4",
                    "value": "59.5"
                  }
                ]
              }
            ]
          }
        ],
        "denoms": [
          {
            "counts": [
              {
                "groupId": "OG000",
                "value": "134"
              },
              {
                "groupId": "OG001",
                "value": "264"
              }
            ],
            "units": "Participants"
          }
        ],
        "description": "Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization.\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
        "dispersionType": "95% Confidence Interval",
        "groups": [
          {
            "description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG000",
            "title": "Placebo+Fulvestrant"
          },
          {
            "description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG001",
            "title": "Taselisib+Fulvestrant"
          }
        ],
        "paramType": "NUMBER",
        "populationDescription": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.",
        "reportingStatus": "POSTED",
        "timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)",
        "title": "Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis",
        "type": "SECONDARY",
        "unitOfMeasure": "percentage of participants"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8",
      "value": {
        "analyses": [
          {
            "ciLowerLimit": "0.23",
            "ciNumSides": "TWO_SIDED",
            "ciPctValue": "95",
            "ciUpperLimit": "2.59",
            "groupIds": [
              "OG000",
              "OG001"
            ],
            "nonInferiorityType": "SUPERIORITY",
            "pValue": "0.6708",
            "paramType": "Hazard Ratio (HR)",
            "paramValue": "0.77",
            "statisticalMethod": "Log Rank"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "comment": "Upper limit of confidence interval was not estimable due to the low number of participants with events.",
                    "groupId": "OG000",
                    "lowerLimit": "6.51",
                    "upperLimit": "NA",
                    "value": "7.23"
                  },
                  {
                    "groupId": "OG001",
                    "lowerLimit": "5.72",
                    "upperLimit": "11.24",
                    "value": "8.74"
                  }
                ]
              }
            ]
          }
        ],
        "denoms": [
          {
            "counts": [
              {
                "groupId": "OG000",
                "value": "16"
              },
              {
                "groupId": "OG001",
                "value": "74"
              }
            ],
            "units": "Participants"
          }
        ],
        "description": "Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nDisease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
        "dispersionType": "95% Confidence Interval",
        "groups": [
          {
            "description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG000",
            "title": "Placebo+Fulvestrant"
          },
          {
            "description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG001",
            "title": "Taselisib+Fulvestrant"
          }
        ],
        "paramType": "MEDIAN",
        "populationDescription": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.\nData are reported for participants with responses.",
        "reportingStatus": "POSTED",
        "timeFrame": "Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
        "title": "Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis",
        "type": "SECONDARY",
        "unitOfMeasure": "months"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9",
      "value": {
        "analyses": [
          {
            "ciLowerLimit": "0.51",
            "ciNumSides": "TWO_SIDED",
            "ciPctValue": "95",
            "ciUpperLimit": "2.35",
            "groupIds": [
              "OG000",
              "OG001"
            ],
            "nonInferiorityType": "SUPERIORITY",
            "pValue": "0.8286",
            "paramType": "Hazard Ratio (HR)",
            "paramValue": "1.09",
            "statisticalMethod": "Log Rank"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "groupId": "OG000",
                    "lowerLimit": "4.67",
                    "upperLimit": "23.95",
                    "value": "7.39"
                  },
                  {
                    "groupId": "OG001",
                    "lowerLimit": "7.36",
                    "upperLimit": "12.91",
                    "value": "8.97"
                  }
                ]
              }
            ]
          }
        ],
        "denoms": [
          {
            "counts": [
              {
                "groupId": "OG000",
                "value": "18"
              },
              {
                "groupId": "OG001",
                "value": "82"
              }
            ],
            "units": "Participants"
          }
        ],
        "description": "Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first.\nCR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).\nPR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.\nDisease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
        "dispersionType": "95% Confidence Interval",
        "groups": [
          {
            "description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG000",
            "title": "Placebo+Fulvestrant"
          },
          {
            "description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG001",
            "title": "Taselisib+Fulvestrant"
          }
        ],
        "paramType": "MEDIAN",
        "populationDescription": "Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.\nData are reported for participants with responses.",
        "reportingStatus": "POSTED",
        "timeFrame": "Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)",
        "title": "Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis",
        "type": "SECONDARY",
        "unitOfMeasure": "months"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/10",
      "value": {
        "analyses": [
          {
            "ciLowerLimit": "0.51",
            "ciNumSides": "TWO_SIDED",
            "ciPctValue": "95",
            "ciUpperLimit": "0.86",
            "groupIds": [
              "OG000",
              "OG001"
            ],
            "nonInferiorityType": "SUPERIORITY",
            "pValue": "0.0023",
            "paramType": "Hazard Ratio (HR)",
            "paramValue": "0.66",
            "statisticalMethod": "Log Rank"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "groupId": "OG000",
                    "lowerLimit": "3.68",
                    "upperLimit": "9.23",
                    "value": "5.39"
                  },
                  {
                    "groupId": "OG001",
                    "lowerLimit": "7.39",
                    "upperLimit": "9.49",
                    "value": "8.97"
                  }
                ]
              }
            ]
          }
        ],
        "denoms": [
          {
            "counts": [
              {
                "groupId": "OG000",
                "value": "176"
              },
              {
                "groupId": "OG001",
                "value": "340"
              }
            ],
            "units": "Participants"
          }
        ],
        "description": "PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
        "dispersionType": "95% Confidence Interval",
        "groups": [
          {
            "description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG000",
            "title": "Placebo+Fulvestrant"
          },
          {
            "description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG001",
            "title": "Taselisib+Fulvestrant"
          }
        ],
        "paramType": "MEDIAN",
        "populationDescription": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.",
        "reportingStatus": "POSTED",
        "timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",
        "title": "PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis",
        "type": "SECONDARY",
        "unitOfMeasure": "months"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/11",
      "value": {
        "analyses": [
          {
            "ciLowerLimit": "0.56",
            "ciNumSides": "TWO_SIDED",
            "ciPctValue": "95",
            "ciUpperLimit": "0.92",
            "groupIds": [
              "OG000",
              "OG001"
            ],
            "nonInferiorityType": "SUPERIORITY",
            "pValue": "0.0095",
            "paramType": "Hazard Ratio (HR)",
            "paramValue": "0.72",
            "statisticalMethod": "Log Rank"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "groupId": "OG000",
                    "lowerLimit": "3.68",
                    "upperLimit": "9.30",
                    "value": "5.55"
                  },
                  {
                    "groupId": "OG001",
                    "lowerLimit": "8.15",
                    "upperLimit": "10.87",
                    "value": "9.20"
                  }
                ]
              }
            ]
          }
        ],
        "denoms": [
          {
            "counts": [
              {
                "groupId": "OG000",
                "value": "176"
              },
              {
                "groupId": "OG001",
                "value": "340"
              }
            ],
            "units": "Participants"
          }
        ],
        "description": "PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier.\nDisease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline.\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nFor non-target lesions, disease progression was defined as unequivocal progression of existing lesions.\nThe appearance of one or more new lesions was also considered progression.",
        "dispersionType": "95% Confidence Interval",
        "groups": [
          {
            "description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG000",
            "title": "Placebo+Fulvestrant"
          },
          {
            "description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG001",
            "title": "Taselisib+Fulvestrant"
          }
        ],
        "paramType": "MEDIAN",
        "populationDescription": "Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.",
        "reportingStatus": "POSTED",
        "timeFrame": "From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)",
        "title": "PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis",
        "type": "SECONDARY",
        "unitOfMeasure": "months"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/12",
      "value": {
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "groupId": "OG000",
                    "value": "89.7"
                  },
                  {
                    "groupId": "OG001",
                    "value": "95.4"
                  }
                ]
              }
            ]
          }
        ],
        "denoms": [
          {
            "counts": [
              {
                "groupId": "OG000",
                "value": "213"
              },
              {
                "groupId": "OG001",
                "value": "416"
              }
            ],
            "units": "Participants"
          }
        ],
        "description": "An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.",
        "groups": [
          {
            "description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG000",
            "title": "Placebo+Fulvestrant"
          },
          {
            "description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG001",
            "title": "Taselisib+Fulvestrant"
          }
        ],
        "paramType": "NUMBER",
        "populationDescription": "The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant.",
        "reportingStatus": "POSTED",
        "timeFrame": "From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.",
        "title": "Percentage of Participants With Adverse Events at Primary Analysis",
        "type": "SECONDARY",
        "unitOfMeasure": "percentage of participants"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/13",
      "value": {
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "groupId": "OG000",
                    "value": "91.1"
                  },
                  {
                    "groupId": "OG001",
                    "value": "97.1"
                  }
                ]
              }
            ]
          }
        ],
        "denoms": [
          {
            "counts": [
              {
                "groupId": "OG000",
                "value": "213"
              },
              {
                "groupId": "OG001",
                "value": "416"
              }
            ],
            "units": "Participants"
          }
        ],
        "description": "An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.",
        "groups": [
          {
            "description": "Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG000",
            "title": "Placebo+Fulvestrant"
          },
          {
            "description": "Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.",
            "id": "OG001",
            "title": "Taselisib+Fulvestrant"
          }
        ],
        "paramType": "NUMBER",
        "populationDescription": "The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant.",
        "reportingStatus": "POSTED",
        "timeFrame": "From randomization up to approximately 6.2 years",
        "title": "Percentage of Participants With Adverse Events at Final Analysis",
        "type": "SECONDARY",
        "unitOfMeasure": "percentage of participants"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/timeFrame",
      "value": "From randomization up to the end of study, approximately 6.2 years"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/description",
      "value": "All-cause mortality was reported based on the ITT population: all randomized participants regardless of whether they received any amount of study treatment.\nSerious and non-serious adverse events were reported based on the safety-evaluable population: all randomized participants who received at least one dose of taselisib, placebo or fulvestrant regardless of the PIK3CA-mutation status of their tumors with participants allocated to the treatment arm associated with the regimen actually received."
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected",
      "value": 100
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk",
      "value": 214
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected",
      "value": 23
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected",
      "value": 183
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAffected",
      "value": 197
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAtRisk",
      "value": 417
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected",
      "value": 154
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/term",
      "value": "ANAEMIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/organSystem",
      "value": "Blood and lymphatic system disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/1/term",
      "value": "PANCYTOPENIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/1/organSystem",
      "value": "Blood and lymphatic system disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/1/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/2/term",
      "value": "ATRIAL FIBRILLATION"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/2/organSystem",
      "value": "Cardiac disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/2/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/3/term",
      "value": "CARDIAC FAILURE CONGESTIVE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/3/organSystem",
      "value": "Cardiac disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/3/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/3/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/4/term",
      "value": "MYOCARDIAL INFARCTION"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/4/organSystem",
      "value": "Cardiac disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/4/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/4/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/5/term",
      "value": "SUPRAVENTRICULAR TACHYCARDIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/5/organSystem",
      "value": "Cardiac disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/5/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/5/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/6/term",
      "value": "ABDOMINAL PAIN"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/6/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/6/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/7/term",
      "value": "ABDOMINAL PAIN UPPER"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/7/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/7/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/8/term",
      "value": "ALCOHOLIC PANCREATITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/8/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/8/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/8/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/9/term",
      "value": "COLITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/9/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/1/numAffected",
      "value": 16
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/9/stats/1/numEvents",
      "value": 17
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/10/term",
      "value": "DIARRHOEA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/10/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/10/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/10/stats/1/numAffected",
      "value": 37
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/10/stats/1/numEvents",
      "value": 40
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/11/term",
      "value": "DYSPEPSIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/11/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/11/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/11/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/12/term",
      "value": "DYSPHAGIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/12/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/12/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/12/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/13/term",
      "value": "ENTERITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/13/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/13/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/13/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/14/term",
      "value": "ENTEROCOLITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/14/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/14/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/14/stats/1/numAffected",
      "value": 3
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/14/stats/1/numEvents",
      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/15/term",
      "value": "GASTRIC ULCER"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/15/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/15/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/15/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/16/term",
      "value": "GASTRITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/16/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/16/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/16/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/16/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/17/term",
      "value": "NAUSEA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/17/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/17/stats/0/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/17/stats/0/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/17/stats/1/numAffected",
      "value": 4
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/17/stats/1/numEvents",
      "value": 5
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/18/term",
      "value": "OESOPHAGEAL ULCER"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/18/organSystem",
      "value": "Gastrointestinal disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/18/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/18/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/18/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/18/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/18/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/19/term",
      "value": "OESOPHAGITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/19/organSystem",
      "value": "Gastrointestinal disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/19/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/19/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/19/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/19/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/19/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/20/term",
      "value": "PANCREATITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/20/organSystem",
      "value": "Gastrointestinal disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/20/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/20/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/20/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/20/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/21/term",
      "value": "PANCREATITIS ACUTE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/21/organSystem",
      "value": "Gastrointestinal disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/21/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/21/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/21/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/22/term",
      "value": "SMALL INTESTINAL OBSTRUCTION"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/22/organSystem",
      "value": "Gastrointestinal disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/22/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/22/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/22/stats/1/numEvents",
      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/23/term",
      "value": "STOMATITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/23/organSystem",
      "value": "Gastrointestinal disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/23/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/23/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/23/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/23/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/24/term",
      "value": "VOMITING"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/24/organSystem",
      "value": "Gastrointestinal disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/24/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/24/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/24/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/24/stats/1/numAffected",
      "value": 4
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/24/stats/1/numEvents",
      "value": 4
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/25/term",
      "value": "ASTHENIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/25/organSystem",
      "value": "General disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/25/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/25/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/25/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/26/term",
      "value": "CHEST DISCOMFORT"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/26/organSystem",
      "value": "General disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/26/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/26/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/26/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/26/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/27/term",
      "value": "CHEST PAIN"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/27/organSystem",
      "value": "General disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/27/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/27/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/27/stats/1/numAffected",
      "value": 3
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/27/stats/1/numEvents",
      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/28/term",
      "value": "CHILLS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/28/organSystem",
      "value": "General disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/28/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/28/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/28/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/28/stats/1/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/28/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/29/term",
      "value": "DEATH"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/29/organSystem",
      "value": "General disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/29/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/29/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/29/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/29/stats/1/numAffected",
      "value": 3
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/29/stats/1/numEvents",
      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/30/term",
      "value": "FATIGUE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/30/organSystem",
      "value": "General disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/30/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/30/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/30/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/30/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/30/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/31/term",
      "value": "MUCOSAL INFLAMMATION"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/31/organSystem",
      "value": "General disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/31/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/31/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/32/term",
      "value": "PAIN"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/32/organSystem",
      "value": "General disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/32/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/1/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/32/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/33/term",
      "value": "PYREXIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/33/organSystem",
      "value": "General disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/33/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/0/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/0/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/1/numAffected",
      "value": 3
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/33/stats/1/numEvents",
      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/34/term",
      "value": "SWELLING FACE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/34/organSystem",
      "value": "General disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/34/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/34/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/34/stats/1/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/34/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/35/term",
      "value": "CHOLECYSTITIS ACUTE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/35/organSystem",
      "value": "Hepatobiliary disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/35/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/35/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/35/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/36/term",
      "value": "CHOLELITHIASIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/36/organSystem",
      "value": "Hepatobiliary disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/36/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/36/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/36/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/37/term",
      "value": "HEPATOTOXICITY"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/37/organSystem",
      "value": "Hepatobiliary disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/37/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/37/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/37/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/37/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/38/term",
      "value": "ANAPHYLACTIC SHOCK"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/38/organSystem",
      "value": "Immune system disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/38/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/38/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/38/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/39/term",
      "value": "APPENDICITIS PERFORATED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/39/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/39/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/39/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/39/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/39/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/40/term",
      "value": "ATYPICAL MYCOBACTERIAL PNEUMONIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/40/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/40/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/40/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/40/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/41/term",
      "value": "BRONCHITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/41/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/41/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/41/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/41/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/42/term",
      "value": "CELLULITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/42/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/42/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/42/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/42/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/42/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/42/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/43/term",
      "value": "CHOLERA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/43/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/43/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/43/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/43/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/43/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/43/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/44/term",
      "value": "CLOSTRIDIUM DIFFICILE COLITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/44/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/44/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/44/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/44/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/44/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/44/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/45/term",
      "value": "CYSTITIS ESCHERICHIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/45/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/45/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/45/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/45/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/45/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/46/term",
      "value": "DIARRHOEA INFECTIOUS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/46/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/46/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/46/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/46/stats/1/numAffected",
      "value": 3
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/46/stats/1/numEvents",
      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/47/term",
      "value": "ENTEROCOLITIS INFECTIOUS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/47/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/47/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/47/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/47/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/47/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/48/term",
      "value": "GASTROENTERITIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/48/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/48/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/48/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/48/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/48/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/49/term",
      "value": "GASTROENTERITIS VIRAL"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/49/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/49/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/49/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/49/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/50/term",
      "value": "HERPES ZOSTER"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/50/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/50/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/50/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/50/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/51/term",
      "value": "LOWER RESPIRATORY TRACT INFECTION"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/51/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/51/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/51/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/51/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/52/term",
      "value": "PNEUMONIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/52/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/52/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/52/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/52/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/52/stats/1/numAffected",
      "value": 10
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/52/stats/1/numEvents",
      "value": 10
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/53/term",
      "value": "RESPIRATORY TRACT INFECTION"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/53/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/53/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/53/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/53/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/54/term",
      "value": "SEPSIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/54/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/54/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/54/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/54/stats/1/numAffected",
      "value": 5
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/54/stats/1/numEvents",
      "value": 5
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/55/term",
      "value": "SEPTIC ARTHRITIS STAPHYLOCOCCAL"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/55/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/55/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/55/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/55/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/55/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/56/term",
      "value": "SKIN INFECTION"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/56/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/56/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/56/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/56/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/56/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/57/term",
      "value": "URINARY TRACT INFECTION"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/57/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/57/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/57/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/57/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/57/stats/1/numAffected",
      "value": 3
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/57/stats/1/numEvents",
      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/58/term",
      "value": "UROSEPSIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/58/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/58/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/58/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/58/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/59/term",
      "value": "VIRAL INFECTION"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/59/organSystem",
      "value": "Infections and infestations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/59/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/59/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/59/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/60/term",
      "value": "CLAVICLE FRACTURE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/60/organSystem",
      "value": "Injury, poisoning and procedural complications"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/60/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/60/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/60/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/61/term",
      "value": "FALL"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/61/organSystem",
      "value": "Injury, poisoning and procedural complications"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/61/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/61/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/61/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/61/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/62/term",
      "value": "FEMORAL NECK FRACTURE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/62/organSystem",
      "value": "Injury, poisoning and procedural complications"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/62/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/62/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/62/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/63/term",
      "value": "FEMUR FRACTURE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/63/organSystem",
      "value": "Injury, poisoning and procedural complications"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/63/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/63/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/63/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/63/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/64/term",
      "value": "HIP FRACTURE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/64/organSystem",
      "value": "Injury, poisoning and procedural complications"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/64/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/64/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/64/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/64/stats/1/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/64/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/65/term",
      "value": "JOINT DISLOCATION"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/65/organSystem",
      "value": "Injury, poisoning and procedural complications"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/65/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/65/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/65/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/66/term",
      "value": "TOXICITY TO VARIOUS AGENTS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/66/organSystem",
      "value": "Injury, poisoning and procedural complications"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/66/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/66/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/66/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/67/term",
      "value": "WRIST FRACTURE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/67/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/67/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/67/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/67/stats/1/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/67/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/68/term",
      "value": "ALANINE AMINOTRANSFERASE INCREASED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/68/organSystem",
      "value": "Investigations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/68/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/68/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/68/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/68/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/68/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/69/term",
      "value": "ASPARTATE AMINOTRANSFERASE INCREASED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/69/organSystem",
      "value": "Investigations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/69/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/69/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/69/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/69/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/70/term",
      "value": "WHITE BLOOD CELL COUNT DECREASED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/70/organSystem",
      "value": "Investigations"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/70/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/70/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/70/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/70/stats/1/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/70/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/71/term",
      "value": "DECREASED APPETITE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/71/organSystem",
      "value": "Metabolism and nutrition disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/71/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/71/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/71/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/72/term",
      "value": "DEHYDRATION"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/72/organSystem",
      "value": "Metabolism and nutrition disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/72/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/72/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/72/stats/1/numAffected",
      "value": 7
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/72/stats/1/numEvents",
      "value": 7
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/73/term",
      "value": "HYPERGLYCAEMIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/73/organSystem",
      "value": "Metabolism and nutrition disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/73/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/73/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/73/stats/1/numAffected",
      "value": 7
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/73/stats/1/numEvents",
      "value": 7
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/74/term",
      "value": "ARTHRALGIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/74/organSystem",
      "value": "Musculoskeletal and connective tissue disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/74/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/74/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/74/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/74/stats/1/numEvents",
      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/75/term",
      "value": "BACK PAIN"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/75/organSystem",
      "value": "Musculoskeletal and connective tissue disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/75/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/75/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/75/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/76/term",
      "value": "COCCYDYNIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/76/organSystem",
      "value": "Musculoskeletal and connective tissue disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/76/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/76/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/76/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/77/term",
      "value": "MUSCLE SPASMS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/77/organSystem",
      "value": "Musculoskeletal and connective tissue disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/77/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/77/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/77/stats/0/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/77/stats/1/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/77/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/78/term",
      "value": "MUSCULAR WEAKNESS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/78/organSystem",
      "value": "Musculoskeletal and connective tissue disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/78/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/78/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/78/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/79/term",
      "value": "OSTEONECROSIS OF JAW"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/79/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/79/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/79/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/79/stats/1/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/79/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/80/term",
      "value": "RHABDOMYOLYSIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/80/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/80/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/80/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/81/term",
      "value": "HEPATOCELLULAR CARCINOMA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/81/organSystem",
      "value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/81/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/81/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/81/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/82/term",
      "value": "INTRACRANIAL TUMOUR HAEMORRHAGE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/82/organSystem",
      "value": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/82/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/82/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/82/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/83/term",
      "value": "CEREBRAL HAEMATOMA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/83/organSystem",
      "value": "Nervous system disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/83/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/83/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/83/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/83/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/83/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/84/term",
      "value": "CEREBROVASCULAR ACCIDENT"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/84/organSystem",
      "value": "Nervous system disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/84/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/84/stats/0/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/84/stats/0/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/84/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/84/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/85/term",
      "value": "FACIAL PARALYSIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/85/organSystem",
      "value": "Nervous system disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/85/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/85/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/85/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/86/term",
      "value": "HEADACHE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/86/organSystem",
      "value": "Nervous system disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/86/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/86/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/86/stats/1/numAffected",
      "value": 3
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/86/stats/1/numEvents",
      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/87/term",
      "value": "HYPOAESTHESIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/87/organSystem",
      "value": "Nervous system disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/87/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/87/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/87/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/87/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/88/term",
      "value": "TRANSIENT ISCHAEMIC ATTACK"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/88/organSystem",
      "value": "Nervous system disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/88/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/88/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/88/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/89/term",
      "value": "TRIGEMINAL NEURALGIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/89/organSystem",
      "value": "Nervous system disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/89/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/89/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/89/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/90/term",
      "value": "VITH NERVE PARALYSIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/90/organSystem",
      "value": "Nervous system disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/90/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/90/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/90/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/90/stats/1/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/90/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/91/term",
      "value": "CONFUSIONAL STATE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/91/organSystem",
      "value": "Psychiatric disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/91/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/91/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/91/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/92/term",
      "value": "MENTAL STATUS CHANGES"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/92/organSystem",
      "value": "Psychiatric disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/92/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/92/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/92/stats/1/numAffected",
      "value": 2
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/92/stats/1/numEvents",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/93/term",
      "value": "ACUTE KIDNEY INJURY"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/93/organSystem",
      "value": "Renal and urinary disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/93/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/93/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/93/stats/1/numAffected",
      "value": 4
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/93/stats/1/numEvents",
      "value": 4
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/94/term",
      "value": "HAEMATURIA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/94/organSystem",
      "value": "Renal and urinary disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/94/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/94/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/94/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/95/term",
      "value": "RENAL FAILURE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/95/organSystem",
      "value": "Renal and urinary disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/95/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/95/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/95/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/95/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/95/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/96/term",
      "value": "URETEROLITHIASIS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/96/organSystem",
      "value": "Renal and urinary disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/96/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/96/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/96/stats/1/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/96/stats/1/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/97/term",
      "value": "INTERMENSTRUAL BLEEDING"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/97/organSystem",
      "value": "Reproductive system and breast disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/97/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/97/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/97/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/97/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/98/term",
      "value": "ACUTE RESPIRATORY DISTRESS SYNDROME"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/98/organSystem",
      "value": "Respiratory, thoracic and mediastinal disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/98/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/98/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/98/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/99/term",
      "value": "ACUTE RESPIRATORY FAILURE"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/99/organSystem",
      "value": "Respiratory, thoracic and mediastinal disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/99/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/99/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/99/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/100/term",
      "value": "COUGH"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/100/organSystem",
      "value": "Respiratory, thoracic and mediastinal disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/100/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/100/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/100/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/100/stats/1/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/100/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/101/term",
      "value": "DYSPNOEA"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/101/organSystem",
      "value": "Respiratory, thoracic and mediastinal disorders"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/101/sourceVocabulary",
      "value": "MedDRA version 24.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/101/stats/0/numAffected",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/101/stats/0/numEvents",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/101/stats/1/numEvents",
      "value": 1
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/102",
      "value": {
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "sourceVocabulary": "MedDRA version 24.0",
        "stats": [
          {
            "groupId": "EG000",
            "numAffected": 0,
            "numAtRisk": 213,
            "numEvents": 0
          },
          {
            "groupId": "EG001",
            "numAffected": 1,
            "numAtRisk": 416,
            "numEvents": 1
          }
        ],
        "term": "INTERSTITIAL LUNG DISEASE"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/103",
      "value": {
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "sourceVocabulary": "MedDRA version 24.0",
        "stats": [
          {
            "groupId": "EG000",
            "numAffected": 2,
            "numAtRisk": 213,
            "numEvents": 2
          },
          {
            "groupId": "EG001",
            "numAffected": 1,
            "numAtRisk": 416,
            "numEvents": 2
          }
        ],
        "term": "PLEURAL EFFUSION"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/104",
      "value": {
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "sourceVocabulary": "MedDRA version 24.0",
        "stats": [
          {
            "groupId": "EG000",
            "numAffected": 1,
            "numAtRisk": 213,
            "numEvents": 1
          },
          {
            "groupId": "EG001",
            "numAffected": 0,
            "numAtRisk": 416,
            "numEvents": 0
          }
        ],
        "term": "PLEURITIC PAIN"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/105",
      "value": {
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "sourceVocabulary": "MedDRA version 24.0",
        "stats": [
          {
            "groupId": "EG000",
            "numAffected": 1,
            "numAtRisk": 213,
            "numEvents": 1
          },
          {
            "groupId": "EG001",
            "numAffected": 10,
            "numAtRisk": 416,
            "numEvents": 10
          }
        ],
        "term": "PNEUMONITIS"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/106",
      "value": {
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "sourceVocabulary": "MedDRA version 24.0",
        "stats": [
          {
            "groupId": "EG000",
            "numAffected": 0,
            "numAtRisk": 213,
            "numEvents": 0
          },
          {
            "groupId": "EG001",
            "numAffected": 2,
            "numAtRisk": 416,
            "numEvents": 2
          }
        ],
        "term": "PNEUMOTHORAX"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/107",
      "value": {
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "sourceVocabulary": "MedDRA version 24.0",
        "stats": [
          {
            "groupId": "EG000",
            "numAffected": 0,
            "numAtRisk": 213,
            "numEvents": 0
          },
          {
            "groupId": "EG001",
            "numAffected": 1,
            "numAtRisk": 416,
            "numEvents": 1
          }
        ],
        "term": "PULMONARY EMBOLISM"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/108",
      "value": {
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "sourceVocabulary": "MedDRA version 24.0",
        "stats": [
          {
            "groupId": "EG000",
            "numAffected": 1,
            "numAtRisk": 213,
            "numEvents": 1
          },
          {
            "groupId": "EG001",
            "numAffected": 0,
            "numAtRisk": 416,
            "numEvents": 0
          }
        ],
        "term": "PULMONARY OEDEMA"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/109",
      "value": {
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "sourceVocabulary": "MedDRA version 24.0",
        "stats": [
          {
            "groupId": "EG000",
            "numAffected": 0,
            "numAtRisk": 213,
            "numEvents": 0
          },
          {
            "groupId": "EG001",
            "numAffected": 1,
            "numAtRisk": 416,
            "numEvents": 1
          }
        ],
        "term": "RESPIRATORY FAILURE"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/110",
      "value": {
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "organSystem": "Skin and subcutaneous tissue disorders",
        "sourceVocabulary": "MedDRA version 24.0",
        "stats": [
          {
            "groupId": "EG000",
            "numAffected": 0,
            "numAtRisk": 213,
            "numEvents": 0
          },
          {
            "groupId": "EG001",
            "numAffected": 1,
            "numAtRisk": 416,
            "numEvents": 1
          }
        ],
        "term": "DRUG ERUPTION"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/111",
      "value": {
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "organSystem": "Skin and subcutaneous tissue disorders",
        "sourceVocabulary": "MedDRA version 24.0",
        "stats": [
          {
            "groupId": "EG000",
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    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT02340221/history/62?patchToVersion=63",
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  "review_question": "Does the public registry record give a specific explanation for the stopped or terminal status?",
  "schema": "trialdiff.evidence_record",
  "trial": {
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    "nct_id": "NCT02340221"
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  "versions": {
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    "submitted_date": "2022-07-11",
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}